LOPERAMIDE acute Heumann Loperamide hydrochloride tablets 10 pc

HEUMANN PHARMA GmbH & Co. Generica KG

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Loperamide akut Heumann

Active substance: Loperamide hydrochloride

For use in adults and children from 12 years.

Area of ​​application: For the symptomatic treatment of acute diarrhea, if no causal therapy is available. Treatment with loperamide for more than 2 days may only be carried out under medical prescription and monitoring of the course.

For Loperamide hydrochloride information on risks and side effects, read the package insert and ask your doctor or pharmacist.
Status: 05/2017

Loperamide hydrochloride Active ingredients

  • 2 mg loperamide hydrochloride

Loperamide hydrochloride Auxiliary materials

  • Cellulose, microcrystalline
  • Croscarmellose sodium
  • Silica, finely divided
  • Magnesium stearate (vegetable)

Loperamide hydrochloride Indication / application

  • Loperamide is a remedy for diarrhea.
  • For the symptomatic treatment of acute diarrhea for adults and children from 12 years of age, if no causal therapy is available.
  • Treatment with loperamide for more than 2 days may only be carried out under medical prescription and monitoring of the course.

Loperamide hydrochloride dosage

  • Always take the medicine exactly as directed.
  • Please ask your doctor or pharmacist if you are not sure.
  • Unless otherwise prescribed by your doctor, the usual dose is:
    • adult
      • First dose: 2 tablets (equivalent to 4 mg loperamide hydrochloride)
      • Repeat dose: 1 tablet (equivalent to 2 mg loperamide hydrochloride)
      • Maximum daily dose: 6 tablets (equivalent to 12mg loperamide hydrochloride)
    • Youth from 12 years
      • Initial dose: 1 tablet (equivalent to 2 mg loperamide hydrochloride)
      • Repeat dose: 1 tablet (equivalent to 2 mg loperamide hydrochloride)
      • Maximum daily dose: 4 tablets (equivalent to 8 mg loperamide hydrochloride)
    • At the beginning of the treatment of acute diarrhea, the first dose is taken.
    • Thereafter, the repeat dose should be taken after each unformed stool.
    • The recommended maximum daily dose must not be exceeded.
  • Children under 12 years:
    • Medicines with a high content of active substances are not suitable for children under 12 years of age. For this purpose, other dosage forms are available according to a doctor's prescription

 

  • Duration of application:
    • Do not take the medicine for more than 2 days without medical advice.
    • If the diarrhea persists after 2 days of treatment, the drug should be discontinued and a doctor should be consulted.
    • Treatment with drugs containing loperamide for longer than 2 days may only be carried out under medical prescription and monitoring of the course.

 

  • Please talk to your doctor or pharmacist if you have the impression that the effect of the drug is too strong or too weak.

 

  • If you take more than you should
    • Consult a doctor as soon as possible, especially if you experience any unusual symptoms (see notes for the doctor).
    • Informations for the doctor:
      • Signs of an overdose are constipation, urinary retention, intestinal obstruction and symptoms of poisoning of the central nervous system (neurotoxicity) such as cramps, indifference (apathy), drowsiness (somnolence), increased and involuntary muscle movements (choreoathetosis), disruption of the coordination of movement sequences (ataxia) Breathing (respiratory depression).
      • The treatment depends on the symptoms of overdose and the clinical picture.
      • With medical follow-up, the opioid antagonist naloxone can be used as an antidote on a trial basis. Since loperamide has a longer duration of action than naloxone, repeated administration of naloxone may be indicated. The patient should therefore be closely monitored for at least 48 hours in order to detect a possible (re) occurrence of overdose symptoms.
      • A gastric lavage can be performed to remove any drug residues that are still in the stomach.

 

  • If you forget to take a dose
    • Do not take a double dose to make up for a forgotten dose.
    • If you have any further questions on the use of the medicinal product, ask your doctor or pharmacist.


Loperamide hydrochloride way

  • Please swallow the tablets whole with sufficient liquid (preferably a glass of water).

Loperamide hydrochloride Side effects

  • Like all medicines, this medicine can have side effects, although not every person treated will experience them.
  • The frequency of side effects is based on the following categories:
    • Very common: affects more than 1 in 10 people
    • Common: affects 1 to 10 users in 100
    • Uncommon: affects 1 to 10 users in 1,000
    • Rare: affects 1 to 10 users in 10,000
    • Very rare: less than 1 in 10,000 patients treated
    • Not known: frequency cannot be estimated from the available data
  • Possible side effects:
    • Clinical trial data
      • The most commonly reported undesirable effects in clinical trials were constipation and dizziness.
      • The following side effects were seen in clinical studies:
        • Diseases of the gastrointestinal tract:
          • Often:
            • constipation
            • Dry mouth
            • Flatulence
            • abdominal cramps
            • Colic
            • nausea
            • Vomit
            • stomach pain
        • Nervous system disorders:
          • Often:
            • dizziness
            • headache
    • Post-marketing experience (the frequency of these side effects is unknown as it cannot be estimated from the available data):
      • Immune system disorders
        • Allergic reactions and in some cases severe hypersensitivity reactions including anaphylactic shock / anaphylactoid reactions.
      • Psychiatric illnesses
        • sleepiness
      • Nervous system disorders
        • fatigue
      • Gastrointestinal disorders
        • Intestinal obstruction
        • distended body
        • Colon enlargement (as a complication, e.g. of a chronic inflammatory bowel disease)
        • Indigestion
      • Skin and subcutaneous tissue disorders
        • skin rash
        • Hives
        • itching
        • Angioedema
        • Blistering skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis
        • Sudden inflammatory disease of the skin or mucous membranes (erythema multiforme)
      • Kidney and urinary tract disorders
        • Urinary retention
  • Please inform your doctor or pharmacist if one of the side effects gets serious, or if you notice side effects not listed here.

Loperamide hydrochloride Interactions

  • Please inform your doctor or pharmacist if you are taking / using or have recently taken / used any other medicines, including medicines obtained without a prescription.
  • In particular, please talk to your doctor if you have to take one or more of the following drugs regularly or occasionally:
    • Ritonavir (used to treat HIV infection)
    • Itraconazole (used to treat a fungal infection)
    • Quinidine (used to treat irregular heartbeat)
    • Gemfibrozil (used to treat high blood lipids)
  • Medicines that suppress stomach and intestinal activity (e.g. opioids = strong painkillers) can increase the effectiveness of the medicament.

 

  • When taken with food and drink
    • Do not drink alcohol during use.

Loperamide hydrochloride Contraindications

  • The medicine must not be taken
    • if you are hypersensitive (allergic) to loperamide hydrochloride or any of the other ingredients.
    • by children under 12 years of age.
    • if you suffer from conditions in which slow bowel movements should be avoided, e.g. B. suffer with distended abdomen, constipation and intestinal obstruction.
    • if you have diarrhea with fever and / or bloody stools.
    • if you have diarrhea that occurs during or after taking antibiotics (pseudomembranous colitis).
    • if you suffer from chronic diarrheal diseases. (These diseases may only be treated with loperamide if prescribed by a doctor.)
    • if you have an acute flare-up of ulcerative colitis (inflammation of the colon).
  • Children under 2 years of age should not be treated with drugs containing loperamide, such as this one.

Loperamide hydrochloride pregnancy and breast feeding period

  • Ask your doctor or pharmacist for advice before taking / using any medicine.
  • Pregnancy:
    • Even if no clear indications of a teratogenic effect were found in a limited number of women (approx. 800) who took the active ingredient of the drug during pregnancy, you should not use the drug during pregnancy.
  • Breastfeeding
    • As small amounts of the active ingredient can pass into breast milk, you should not use the drug if you are breastfeeding.

Loperamide hydrochloride Patient information

  • What to consider with children
    • Children under 2 years of age must not use drugs containing loperamide, such as B. be treated with this medicine.
    • Children between 2 and 12 years of age may only be treated with drugs containing loperamide as prescribed by a doctor. Due to the high content of active ingredients, the preparation is not suitable for this age group. For this purpose, other dosage forms are available according to a doctor's prescription.
  • Take special care when taking:
    • if you have AIDS and you are taking the medicine to treat diarrhea. At the first sign of a bloated body, you should stop taking the drug and see your doctor. There are individual reports of severe inflammatory enlargement of the large intestine (toxic megacolon) in AIDS patients. They suffered from an infectious colon inflammation (colitis) caused by viral and bacterial pathogens and were treated with loperamide.
    • if you suffer from liver disease, consult your doctor before taking.
      • The medicinal product may only be used according to a doctor's prescription if there is or has been through liver disease, because the breakdown of loperamide may be delayed in severe liver disease.
    • make sure that there is sufficient replacement of fluids and salts (electrolytes). This is the most important treatment measure for diarrhea, as it can lead to a large loss of fluid and salt. This is especially true for children.
  • The medicine causes the diarrhea to stop, but does not remove the cause. If possible, the cause should also be treated. Therefore speak to your doctor.
  • The recommended dosage and the duration of use of 2 days must not be exceeded because severe constipation can occur.
  • If the diarrhea persists after 2 days of treatment, the drug should be discontinued and a doctor should be consulted.

 

  • Driving and using machines:
    • If you have diarrhea or as a result of taking the drug, you may feel tired, dizzy and sleepy. Therefore, caution is advised in traffic or when working with machines.